Surgery

Obstetricians know that a cesarean delivery (CD) for a woman with a prolonged second stage and a fetal head deeply impacted in the pelvis is challenging. In this situation, extensions of the uterine incision commonly occur, resulting in prolonged operative time and increased blood loss. Even more harrowing is the inability to deliver the fetal head, necessitating emergency assistance from other clinicians. In this situation, interventions that may be helpful include:

• extend or T the uterine incision
• enlist the aid of a clinician to push up on the fetal head with a vaginal hand (FIGURE 1)
• reverse breech extraction (FIGURE 2), and
• vaginal insertion of a Fetal Pillow prior to starting the delivery.

Evidence from clinical trials indicates that reverse breech extraction or insertion of a Fetal Pillow result in the best clinical outcomes.

Reverse breech extraction vs the push technique

Although the data are limited, most studies report that compared with pushing up with a vaginal hand (as shown in Figure 1), the reverse breech extraction technique (as shown in Figure 2) is associated with a reduction in extensions of the uterine incision, reduced blood loss, and reduced operative time.¹ In a randomized trial, 108 women with obstructed labor undergoing CD in the second stage were randomly assigned to reverse breech extraction or pushing up with a vaginal hand.² Following the uterine incision, the reverse breech extraction technique is performed by immediately reaching into the upper uterus and grasping the lower portion of the fetal leg and applying gentle traction on the leg until the second leg appeared. The lower legs are then pulled out of the uterus. Standard breech delivery maneuvers are used to deliver the shoulders and head. In the trial, compared with the push technique, reverse breech extraction was associated with fewer extensions of the uterine incision (30% vs 11%; P<.05), less blood loss (899 mL vs 1,257 mL; P<.001), and shorter operative time (56 min vs 89 min, P<.001). Fetal injury was similar with the push and breech extraction techniques (6% and 7%).

In another randomized trial, 192 women undergoing CD for obstructed labor were randomly assigned to reverse breech extraction or pushing the head up with a hand in the vagina.³ Compared with the vaginal push technique, reverse breech extraction was associated with fewer extensions of the uterine incision (19% vs 48%; P = .003), fewer cases of wound infection (2% vs 13%; P = .007), and fewer blood transfusions (2 vs 11; P = .012).

Additional options and adjuvants for facilitating delivery of a fetal head deeply impacted in the pelvis include: using a Coyne spoon, using nitroglycerine or terbutaline to relax the myometrium, breaking the vaginal suction on the fetal head before attempting delivery, keeping the wrist of the delivering hand as straight as possible to reduce uterine incision extensions, and incising the ring (if a Bandl’s ring is detected).

Continue to: The Fetal Pillow...

The Fetal Pillow

The Fetal Pillow (Safe Obstetric Systems, New York, New York) is a single-use fetal cephalic elevation device for managing the deeply impacted fetal head (FIGURE 3). The Fetal Pillow has a firm plastic base upon which is attached a soft silicon balloon. The Fetal Pillow is inserted into the vagina prior to initiating CD and the balloon is filled with 180 mL of saline, causing the fetal head to be pushed to a higher station (FIGURE 4). Use of the Fetal Pillow may be indicated prior to CD in the following situations:

• second stage labor with a deeply impacted head
• second stage labor and failed operative delivery
• occiput posterior position or deep transverse arrest
• absent progress in the first stage between 8 cm and 10 cm with a deeply impacted fetal head or excessive caput of the fetal head.

The Fetal Pillow is inserted after completing vaginal preparation for CD and before initiating skin preparation and abdominal draping. The steps for inserting the Fetal Pillow include:

1. Use the 60 mL syringe to fully deflate the Fetal Pillow and leave the cock-stop open.
2. Fold the Fetal Pillow by squeezing the firm plastic base, and with the patient’s legs in a frog-leg position, place the device in the vagina.
3. Allow the firm plastic base to open to a flat position with the base against the posterior vaginal wall and the soft silicon balloon against the fetal head.
4. Using pressure on the plastic base, gently push the Fetal Pillow posteriorly toward the sacrum of the mother.
5. Use the 60 mL syringe to inflate the balloon with 180 mL of normal saline and close the valve.
6. Straighten the patient’s legs and proceed with skin preparation and abdominal draping (FIGURE 4).

When the CD is completed, deflate the balloon by drawing out the saline with the 60 mL syringe and remove the device by hooking a finger around the firm plastic base. The Fetal Pillow is surprisingly easy to use.

Continue to: Effectiveness of the Fetal Pillow...

Effectiveness of the Fetal Pillow

In one randomized trial, 240 women undergoing CD were randomly allocated to a group in which the Fetal Pillow was placed in the vagina and inflated prior to the cesarean and a control group in which the Fetal Pillow was not used. In this study the mean length of the second stage averaged 1.9 hours.⁴ Compared with no Fetal Pillow, use of the Fetal Pillow was associated with a reduction in grade 3 extension of the uterine incision (extension into the uterine artery, vagina, or bladder) (2.5% vs 23%), a reduction in blood loss > 1,000 mL (4% vs 22%), and fewer difficult plus very difficult deliveries of the fetal head as reported by the surgeon (6% vs 39%).

In another randomized trial, 60 nulliparous women undergoing CD in the second stage of labor had a Fetal Pillow inserted in the vagina and were randomly allocated to inflation of the pillow (Fetal Pillow group) or noninflation of the pillow (control group).⁵ In this study the mean length of the second stage was 4 hours. Compared with noninflation of the Fetal Pillow, use of the inflated Fetal Pillow was associated with a reduction in grade 3 extension of the uterine incision (extensions into the uterine artery, vagina, or bladder) (0% for inflation vs 13% for noninflation) and fewer difficult plus very difficult deliveries of the fetal head as reported by the surgeon (0% for inflation vs 37% for noninflation). There was no significant difference in blood loss between the two groups (800 mL vs 900 mL). These two randomized studies both reported that the use of the Fetal Pillow was associated with a reduction in grade 3 extensions of the uterine incision and a decrease in the difficulty of delivering the fetal head.

Consider trialing the Fetal Pillow

When a CD is performed after a prolonged second stage of labor, surgical complications are common, including extensions of the uterine incision and difficulty delivering the fetal head. When a grade 3 extension occurs—with tearing of a uterine artery, deep extension into the vagina, or damage to the bladder—the surgical repair can be extraordinarily challenging. Clinical trials report that both reverse breech extraction and the Fetal Pillow can facilitate CD in the setting of a prolonged second stage. For many obstetricians reverse breech extraction is a challenging obstetric maneuver. The insertion and inflation of a Fetal Pillow is a simple procedure. Obstetrician-gynecologists learn by doing. If you have never used the Fetal Pillow, I suggest you consider trialing it in your practice. ●

Obstetricians know that a cesarean delivery (CD) for a woman with a prolonged second stage and a fetal head deeply impacted in the pelvis is challenging. In this situation, extensions of the uterine incision commonly occur, resulting in prolonged operative time and increased blood loss. Even more harrowing is the inability to deliver the fetal head, necessitating emergency assistance from other clinicians. In this situation, interventions that may be helpful include:

• extend or T the uterine incision
• enlist the aid of a clinician to push up on the fetal head with a vaginal hand (FIGURE 1)
• reverse breech extraction (FIGURE 2), and
• vaginal insertion of a Fetal Pillow prior to starting the delivery.

Evidence from clinical trials indicates that reverse breech extraction or insertion of a Fetal Pillow result in the best clinical outcomes.

Reverse breech extraction vs the push technique

Although the data are limited, most studies report that compared with pushing up with a vaginal hand (as shown in Figure 1), the reverse breech extraction technique (as shown in Figure 2) is associated with a reduction in extensions of the uterine incision, reduced blood loss, and reduced operative time.¹ In a randomized trial, 108 women with obstructed labor undergoing CD in the second stage were randomly assigned to reverse breech extraction or pushing up with a vaginal hand.² Following the uterine incision, the reverse breech extraction technique is performed by immediately reaching into the upper uterus and grasping the lower portion of the fetal leg and applying gentle traction on the leg until the second leg appeared. The lower legs are then pulled out of the uterus. Standard breech delivery maneuvers are used to deliver the shoulders and head. In the trial, compared with the push technique, reverse breech extraction was associated with fewer extensions of the uterine incision (30% vs 11%; P<.05), less blood loss (899 mL vs 1,257 mL; P<.001), and shorter operative time (56 min vs 89 min, P<.001). Fetal injury was similar with the push and breech extraction techniques (6% and 7%).

In another randomized trial, 192 women undergoing CD for obstructed labor were randomly assigned to reverse breech extraction or pushing the head up with a hand in the vagina.³ Compared with the vaginal push technique, reverse breech extraction was associated with fewer extensions of the uterine incision (19% vs 48%; P = .003), fewer cases of wound infection (2% vs 13%; P = .007), and fewer blood transfusions (2 vs 11; P = .012).

Additional options and adjuvants for facilitating delivery of a fetal head deeply impacted in the pelvis include: using a Coyne spoon, using nitroglycerine or terbutaline to relax the myometrium, breaking the vaginal suction on the fetal head before attempting delivery, keeping the wrist of the delivering hand as straight as possible to reduce uterine incision extensions, and incising the ring (if a Bandl’s ring is detected).

Continue to: The Fetal Pillow...

The Fetal Pillow

The Fetal Pillow (Safe Obstetric Systems, New York, New York) is a single-use fetal cephalic elevation device for managing the deeply impacted fetal head (FIGURE 3). The Fetal Pillow has a firm plastic base upon which is attached a soft silicon balloon. The Fetal Pillow is inserted into the vagina prior to initiating CD and the balloon is filled with 180 mL of saline, causing the fetal head to be pushed to a higher station (FIGURE 4). Use of the Fetal Pillow may be indicated prior to CD in the following situations:

• second stage labor with a deeply impacted head
• second stage labor and failed operative delivery
• occiput posterior position or deep transverse arrest
• absent progress in the first stage between 8 cm and 10 cm with a deeply impacted fetal head or excessive caput of the fetal head.

The Fetal Pillow is inserted after completing vaginal preparation for CD and before initiating skin preparation and abdominal draping. The steps for inserting the Fetal Pillow include:

1. Use the 60 mL syringe to fully deflate the Fetal Pillow and leave the cock-stop open.
2. Fold the Fetal Pillow by squeezing the firm plastic base, and with the patient’s legs in a frog-leg position, place the device in the vagina.
3. Allow the firm plastic base to open to a flat position with the base against the posterior vaginal wall and the soft silicon balloon against the fetal head.
4. Using pressure on the plastic base, gently push the Fetal Pillow posteriorly toward the sacrum of the mother.
5. Use the 60 mL syringe to inflate the balloon with 180 mL of normal saline and close the valve.
6. Straighten the patient’s legs and proceed with skin preparation and abdominal draping (FIGURE 4).

When the CD is completed, deflate the balloon by drawing out the saline with the 60 mL syringe and remove the device by hooking a finger around the firm plastic base. The Fetal Pillow is surprisingly easy to use.

Continue to: Effectiveness of the Fetal Pillow...

Effectiveness of the Fetal Pillow

In one randomized trial, 240 women undergoing CD were randomly allocated to a group in which the Fetal Pillow was placed in the vagina and inflated prior to the cesarean and a control group in which the Fetal Pillow was not used. In this study the mean length of the second stage averaged 1.9 hours.⁴ Compared with no Fetal Pillow, use of the Fetal Pillow was associated with a reduction in grade 3 extension of the uterine incision (extension into the uterine artery, vagina, or bladder) (2.5% vs 23%), a reduction in blood loss > 1,000 mL (4% vs 22%), and fewer difficult plus very difficult deliveries of the fetal head as reported by the surgeon (6% vs 39%).

In another randomized trial, 60 nulliparous women undergoing CD in the second stage of labor had a Fetal Pillow inserted in the vagina and were randomly allocated to inflation of the pillow (Fetal Pillow group) or noninflation of the pillow (control group).⁵ In this study the mean length of the second stage was 4 hours. Compared with noninflation of the Fetal Pillow, use of the inflated Fetal Pillow was associated with a reduction in grade 3 extension of the uterine incision (extensions into the uterine artery, vagina, or bladder) (0% for inflation vs 13% for noninflation) and fewer difficult plus very difficult deliveries of the fetal head as reported by the surgeon (0% for inflation vs 37% for noninflation). There was no significant difference in blood loss between the two groups (800 mL vs 900 mL). These two randomized studies both reported that the use of the Fetal Pillow was associated with a reduction in grade 3 extensions of the uterine incision and a decrease in the difficulty of delivering the fetal head.

Consider trialing the Fetal Pillow

When a CD is performed after a prolonged second stage of labor, surgical complications are common, including extensions of the uterine incision and difficulty delivering the fetal head. When a grade 3 extension occurs—with tearing of a uterine artery, deep extension into the vagina, or damage to the bladder—the surgical repair can be extraordinarily challenging. Clinical trials report that both reverse breech extraction and the Fetal Pillow can facilitate CD in the setting of a prolonged second stage. For many obstetricians reverse breech extraction is a challenging obstetric maneuver. The insertion and inflation of a Fetal Pillow is a simple procedure. Obstetrician-gynecologists learn by doing. If you have never used the Fetal Pillow, I suggest you consider trialing it in your practice. ●

Obstetricians know that a cesarean delivery (CD) for a woman with a prolonged second stage and a fetal head deeply impacted in the pelvis is challenging. In this situation, extensions of the uterine incision commonly occur, resulting in prolonged operative time and increased blood loss. Even more harrowing is the inability to deliver the fetal head, necessitating emergency assistance from other clinicians. In this situation, interventions that may be helpful include:

• extend or T the uterine incision
• enlist the aid of a clinician to push up on the fetal head with a vaginal hand (FIGURE 1)
• reverse breech extraction (FIGURE 2), and
• vaginal insertion of a Fetal Pillow prior to starting the delivery.

Evidence from clinical trials indicates that reverse breech extraction or insertion of a Fetal Pillow result in the best clinical outcomes.

Reverse breech extraction vs the push technique

Although the data are limited, most studies report that compared with pushing up with a vaginal hand (as shown in Figure 1), the reverse breech extraction technique (as shown in Figure 2) is associated with a reduction in extensions of the uterine incision, reduced blood loss, and reduced operative time.¹ In a randomized trial, 108 women with obstructed labor undergoing CD in the second stage were randomly assigned to reverse breech extraction or pushing up with a vaginal hand.² Following the uterine incision, the reverse breech extraction technique is performed by immediately reaching into the upper uterus and grasping the lower portion of the fetal leg and applying gentle traction on the leg until the second leg appeared. The lower legs are then pulled out of the uterus. Standard breech delivery maneuvers are used to deliver the shoulders and head. In the trial, compared with the push technique, reverse breech extraction was associated with fewer extensions of the uterine incision (30% vs 11%; P<.05), less blood loss (899 mL vs 1,257 mL; P<.001), and shorter operative time (56 min vs 89 min, P<.001). Fetal injury was similar with the push and breech extraction techniques (6% and 7%).

In another randomized trial, 192 women undergoing CD for obstructed labor were randomly assigned to reverse breech extraction or pushing the head up with a hand in the vagina.³ Compared with the vaginal push technique, reverse breech extraction was associated with fewer extensions of the uterine incision (19% vs 48%; P = .003), fewer cases of wound infection (2% vs 13%; P = .007), and fewer blood transfusions (2 vs 11; P = .012).

Additional options and adjuvants for facilitating delivery of a fetal head deeply impacted in the pelvis include: using a Coyne spoon, using nitroglycerine or terbutaline to relax the myometrium, breaking the vaginal suction on the fetal head before attempting delivery, keeping the wrist of the delivering hand as straight as possible to reduce uterine incision extensions, and incising the ring (if a Bandl’s ring is detected).

Continue to: The Fetal Pillow...

The Fetal Pillow

The Fetal Pillow (Safe Obstetric Systems, New York, New York) is a single-use fetal cephalic elevation device for managing the deeply impacted fetal head (FIGURE 3). The Fetal Pillow has a firm plastic base upon which is attached a soft silicon balloon. The Fetal Pillow is inserted into the vagina prior to initiating CD and the balloon is filled with 180 mL of saline, causing the fetal head to be pushed to a higher station (FIGURE 4). Use of the Fetal Pillow may be indicated prior to CD in the following situations:

• second stage labor with a deeply impacted head
• second stage labor and failed operative delivery
• occiput posterior position or deep transverse arrest
• absent progress in the first stage between 8 cm and 10 cm with a deeply impacted fetal head or excessive caput of the fetal head.

The Fetal Pillow is inserted after completing vaginal preparation for CD and before initiating skin preparation and abdominal draping. The steps for inserting the Fetal Pillow include:

1. Use the 60 mL syringe to fully deflate the Fetal Pillow and leave the cock-stop open.
2. Fold the Fetal Pillow by squeezing the firm plastic base, and with the patient’s legs in a frog-leg position, place the device in the vagina.
3. Allow the firm plastic base to open to a flat position with the base against the posterior vaginal wall and the soft silicon balloon against the fetal head.
4. Using pressure on the plastic base, gently push the Fetal Pillow posteriorly toward the sacrum of the mother.
5. Use the 60 mL syringe to inflate the balloon with 180 mL of normal saline and close the valve.
6. Straighten the patient’s legs and proceed with skin preparation and abdominal draping (FIGURE 4).

When the CD is completed, deflate the balloon by drawing out the saline with the 60 mL syringe and remove the device by hooking a finger around the firm plastic base. The Fetal Pillow is surprisingly easy to use.

Continue to: Effectiveness of the Fetal Pillow...

Effectiveness of the Fetal Pillow

In one randomized trial, 240 women undergoing CD were randomly allocated to a group in which the Fetal Pillow was placed in the vagina and inflated prior to the cesarean and a control group in which the Fetal Pillow was not used. In this study the mean length of the second stage averaged 1.9 hours.⁴ Compared with no Fetal Pillow, use of the Fetal Pillow was associated with a reduction in grade 3 extension of the uterine incision (extension into the uterine artery, vagina, or bladder) (2.5% vs 23%), a reduction in blood loss > 1,000 mL (4% vs 22%), and fewer difficult plus very difficult deliveries of the fetal head as reported by the surgeon (6% vs 39%).

In another randomized trial, 60 nulliparous women undergoing CD in the second stage of labor had a Fetal Pillow inserted in the vagina and were randomly allocated to inflation of the pillow (Fetal Pillow group) or noninflation of the pillow (control group).⁵ In this study the mean length of the second stage was 4 hours. Compared with noninflation of the Fetal Pillow, use of the inflated Fetal Pillow was associated with a reduction in grade 3 extension of the uterine incision (extensions into the uterine artery, vagina, or bladder) (0% for inflation vs 13% for noninflation) and fewer difficult plus very difficult deliveries of the fetal head as reported by the surgeon (0% for inflation vs 37% for noninflation). There was no significant difference in blood loss between the two groups (800 mL vs 900 mL). These two randomized studies both reported that the use of the Fetal Pillow was associated with a reduction in grade 3 extensions of the uterine incision and a decrease in the difficulty of delivering the fetal head.

Consider trialing the Fetal Pillow

When a CD is performed after a prolonged second stage of labor, surgical complications are common, including extensions of the uterine incision and difficulty delivering the fetal head. When a grade 3 extension occurs—with tearing of a uterine artery, deep extension into the vagina, or damage to the bladder—the surgical repair can be extraordinarily challenging. Clinical trials report that both reverse breech extraction and the Fetal Pillow can facilitate CD in the setting of a prolonged second stage. For many obstetricians reverse breech extraction is a challenging obstetric maneuver. The insertion and inflation of a Fetal Pillow is a simple procedure. Obstetrician-gynecologists learn by doing. If you have never used the Fetal Pillow, I suggest you consider trialing it in your practice. ●

New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.

In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.

For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.

The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.

“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.

All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.

Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.

The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.

“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.

The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”

Important Differences From Kawasaki Disease

In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).

Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.

The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.

In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.

Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.

Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”

As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.

Questions Remain

With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.

“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.

“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”

Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.

“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”

Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:

• Why do some children get MIS-C and not others?
• What is the long-term outcome of children with MIS-C?
• How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
• Does MIS-C occur in young adults?

Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.

On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”

Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.

This article first appeared on Medscape.com.

New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.

In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.

For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.

The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.

“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.

All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.

Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.

The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.

“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.

The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”

Important Differences From Kawasaki Disease

In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).

Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.

The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.

In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.

Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.

Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”

As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.

Questions Remain

With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.

“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.

“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”

Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.

“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”

Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:

• Why do some children get MIS-C and not others?
• What is the long-term outcome of children with MIS-C?
• How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
• Does MIS-C occur in young adults?

Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.

On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”

Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.

This article first appeared on Medscape.com.

New data from active surveillance of the severe inflammatory condition associated with COVID-19 in previously healthy children provide further insight into the prevalence and course of the rare syndrome, but experts are concerned that current diagnostic criteria may not capture the true scope of the problem.

In separate reports published online June 29 in the New England Journal of Medicine, researchers from the New York State Department of Health and the Centers for Disease Control and Prevention (CDC) describe the epidemiology and clinical features of multisystem inflammatory syndrome in children (MIS-C) on the basis of information derived from targeted surveillance programs in New York State and across the country.

For the New York study, Elizabeth M. Dufort, MD, from the New York Department of Health in Albany and colleagues analyzed MIS-C surveillance data from 106 hospitals across the state. Of 191 suspected MIS-C cases reported to the Department of Health from March 1 through May 10, 99 met the state’s interim case definition of the condition and were included in the analysis.

The incidence rate for MIS-C was two cases per 100,000 individuals younger than 21 years, whereas the incidence rate of confirmed COVID-19 cases in this age group was 322 per 100,000. Most cases occurred approximately 1 month after the state’s COVID-19 peak.

“Among our patients, predominantly from the New York Metropolitan Region, 40% were black and 36% were Hispanic. This may be a reflection of the well-documented elevated incidence of SARS-CoV-2 infection among black and Hispanic communities,” the authors report.

All children presented with fever or chills, and most had tachycardia (97%) and gastrointestinal symptoms (80%). Rash (60%), conjunctival infection (56%), hypotension (32%), and mucosal changes (27%) were reported. Among all of the children, levels of inflammatory markers were elevated, including levels of C-reactive protein (100%), D-dimer (91%), and troponin (71%). More than one third of the patients (36%) were diagnosed with myocarditis, and an additional 16% had clinical myocarditis.

Of the full cohort, 80% of the children required intensive care, 62% received vasopressor support, and two children died.

The high prevalence of cardiac dysfunction or depression, coagulopathy, gastrointestinal symptoms, mild respiratory symptoms, and indications for supplemental oxygen in patients with MIS-C stands in contrast to the clinical picture observed in most acute cases of COVID-19 in hospitalized children, the authors write.

“Although most children have mild or no illness from SARS-CoV-2 infection, MIS-C may follow Covid-19 or asymptomatic SARS-CoV-2 infection. Recognition of the syndrome and early identification of children with MIS-C, including early monitoring of blood pressure and electrocardiographic and echocardiographic evaluation, could inform appropriate supportive care and other potential therapeutic options,” they continue.

The incidence of MIS-C among children infected with SARS-CoV-2 is unclear because children with COVID-19 often have mild or no symptoms and because children are not tested as frequently, the authors state. For this reason, “[i]t is crucial to establish surveillance for MIS-C cases, particularly in communities with higher levels of SARS-CoV-2 transmission.”

Important Differences From Kawasaki Disease

In a separate study, Leora R. Feldstein, MD, of the CDC, and colleagues report 186 cases of MIS-C collected through targeted surveillance of pediatric health centers in 26 US states from March 15 to May 20, 2020. As with the New York cohort, a disproportionate number of children in this cohort were black (25%) and Hispanic or Latino (31%).

Similar to the New York cohort, 80% of the children in this group required intensive care, 48% received vasoactive support, 20% required invasive mechanical ventilation, and four children died. Skin rashes, gastrointestinal symptoms, cardiovascular and hematologic effects, mucous changes, and elevations of inflammatory biomarkers were also similarly observed.

The researchers note that, although many of the features of MIS-C overlap with Kawasaki disease, there are some important differences, particularly with respect to the nature of cardiovascular involvement. “Approximately 5% of children with Kawasaki’s disease in the United States present with cardiovascular shock leading to vasopressor or inotropic support, as compared with 50% of the patients in our series,” the authors write.

In addition, coronary-artery aneurysms affect approximately one quarter of Kawasaki disease patients within 21 days of disease onset. “In our series, a maximum z score of 2.5 or higher in the left anterior descending or right coronary artery was reported in 8% of the patients overall and in 9% of patients with echocardiograms,” they report.

Additional differentiating features include patient age and race/ethnicity. Kawasaki disease occurs most commonly in children younger than 5 years. The median age in the multistate study was 8.3 years, and nearly half of the children in the New York cohort were in the 6- to 12-year age group. Further, Kawasaki disease is disproportionately prevalent in children of Asian descent.

Despite the differences, “until more is known about long-term cardiac sequelae of MIS-C, providers could consider following Kawasaki’s disease guidelines for follow-up, which recommend repeat echocardiographic imaging at 1 to 2 weeks.”

As was the case in the New York series, treatment in the multistate cohort most commonly included intravenous immunoglobulin and systemic glucocorticoids. Optimal management, however, will require a better understanding of the pathogenesis of MIS-C, Feldstein and colleagues write.

Questions Remain

With the accumulating data on this syndrome, the MIS-C picture seems to be getting incrementally clearer, but there is still much uncertainty, according to Michael Levin, FMedSci, PhD, from the Department of Infectious Disease, Imperial College London, United Kingdom.

“The recognition and description of new diseases often resemble the parable of the blind men and the elephant, with each declaring that the part of the beast they have touched fully defines it,” he writes in an accompanying editorial.

“As the coronavirus disease 2019 (Covid-19) pandemic has evolved, case reports have appeared describing children with unusual febrile illnesses that have features of Kawasaki’s disease, toxic shock syndrome, acute abdominal conditions, and encephalopathy, along with other reports of children with fever, elevated inflammatory markers, and multisystem involvement. It is now apparent that these reports were describing different clinical presentations of a new childhood inflammatory disorder.”

Although a consistent clinical picture is emerging, “[t]he published reports have used a variety of hastily developed case definitions based on the most severe cases, possibly missing less serious cases,” Levin writes. In particular, both the CDC and World Health Organization definitions require evidence of SARS-CoV-2 infection or exposure, which might contribute to underrecognition and underreporting because asymptomatic infections are common and antibody testing is not universally available.

“There is concern that children meeting current diagnostic criteria for MIS-C are the ‘tip of the iceberg,’ and a bigger problem may be lurking below the waterline,” Levin states. With approximately 1000 cases of the syndrome reported worldwide, “do we now have a clear picture of the new disorder, or as in the story of the blind men and the elephant, has only part of the beast been described?”

Adrienne Randolph, MD, of Boston Children’s Hospital, who is a coauthor of the multistate report, agrees that there is still much to learn about MIS-C before the whole beast can be understood. In an interview with Medscape Medical News, she listed the following key questions that have yet to be answered:

• Why do some children get MIS-C and not others?
• What is the long-term outcome of children with MIS-C?
• How can we differentiate MIS-C from acute COVID-19 infection in children with respiratory failure?
• Does MIS-C occur in young adults?

Randolph said her team is taking the best path forward toward answering these questions, including conducting a second study to identify risk factors for MIS-C and longer-term follow-up studies with the National Institutes of Health. “We are also getting consent to collect blood samples and look at other tests to help distinguish MIS-C from acute COVID-19 infection,” she said. She encouraged heightened awareness among physicians who care for young adults to consider MIS-C in patients aged 21 years and older who present with similar signs and symptoms.

On the basis of the answers to these and additional questions, the case definitions for MIS-C may need refinement to capture the wider spectrum of illness, Levin writes in his editorial. “The challenges of this new condition will now be to understand its pathophysiological mechanisms, to develop diagnostics, and to define the best treatment.”

Kleinman has received grants from the Health Services Resources Administration outside the submitted work. Maddux has received grants from the NIH/NICHD and the Francis Family Foundation outside the submitted work. Randolph has received grants from Genentech and personal fees from La Jolla Pharma outside the submitted work and others from the CDC during the conduct of the study.

This article first appeared on Medscape.com.

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

For women undergoing urethral diverticulectomy, adding a pubovaginal sling at the time of surgery resolved stress urinary incontinence 79% of the time, a large retrospective cohort study has found.

Alexander Raths/Fotolia

However, in 66% of cases in which the diverticulectomy alone was performed, women also saw their stress urinary incontinence (SUI) resolve.

For a study published online in the American Journal of Obstetrics and Gynecology, Sarah E. Bradley, MD, of Georgetown University in Washington and colleagues analyzed records for 485 urethral diverticulectomies performed at 11 institutions over a 16-year period. One-fifth of patients had an autologous fascial pubovaginal sling (PVS) placed at the time of surgery.

The concomitant sling was associated with a significantly greater reduction of SUI after adjustment for prior diverticulectomy, prior incontinence surgery, age, race, and parity (adjusted odds ratio, 2.27; 95% confidence interval, 1.02-5.03; P = .043).

However, 10% of women in the sling-treated group had recurrent UTI from 6 weeks after surgery, compared with 3% of those in the diverticulectomy-only group (P = .001). Even after adjustment for higher rates of UTI before surgery in the sling group, the odds of recurrent UTI still were higher with the concomitant sling. Women within the sling group also were more likely to experience urinary retention at more than 6 weeks after surgery (8% vs. 1%; P equal to .0001).

Dr. Bradley and her colleagues noted that theirs was the largest study to date evaluating postoperative SUI in patients undergoing diverticulectomy with and without a PVS, noting that many surgeons do not routinely offer the sling at the time of diverticulectomy.

They also acknowledged a selection bias in their study. “With the previously thought theoretical increased risk of the addition of PVS, it is likely that most providers would prefer only to offer this concomitant procedure to those with significantly bothersome SUI. Additionally, the majority of women that underwent PVS (83%) came from two of the 11 participating institutions,” the researchers wrote.

In an interview, Catherine A. Mathews, MD, of Wake Forest University in Winston Salem, N.C., argued for a different interpretation of the study’s results.

“The study was beautifully done and it’s an ideal subject for a review, but in some respect the authors missed the opportunity to highlight that there was a spontaneous resolution of stress incontinence symptoms in 66% of women who received diverticulectomy alone,” Dr. Matthews said, adding that this has important implications for medical decision-making and patient choice.

“Morbidity associated with the pubovaginal sling was very low in this study, probably because it was being done by very proficient surgeons, but in many centers it is higher,” Dr. Matthews said. Even with the overall low morbidity seen in the study, “there was still a significant price to pay” for some women in the pubovaginal sling–treated group. “Recurrent UTI can be challenging to manage in the long term, with antibiotic morbidity and significant symptom bother. For the patients with urinary retention, having to manage it with a catheter is a really awful.”

Dr. Matthews said that the study made a case for interval, rather than concomitant, sling placement in women undergoing urethral diverticulectomy. “If you have a patient who insists on addressing symptoms concomitantly, this study provides good information about the long-term likelihood of two complications: urinary retention and recurrent UTI,” she said. “The vast majority of patients that I’m counseling would choose not to have the sling because of these complications.” And while avoiding reoperation may seem a good reason to opt for the PVS during diverticulectomy, the sling was not associated with a decrease in reoperations, compared with diverticulectomy alone, she noted.

“As we can see in the study, diverticulectomy itself has a high impact on stress incontinence,” Dr. Matthews continued. “If you restore the urethral anatomy and wait for the urethra to heal, you have a very good chance that the incontinence resolves.” For those women who do not see resolution and whose symptoms are still severe enough to bother them, “you’d have the flexibility postoperatively to offer not only a pubovaginal sling, but a synthetic mesh sling or a urethral bulking procedure.”

Dr. Bradley and her colleagues reported no relevant financial disclosures. Dr. Matthews disclosed financial support from Boston Scientific and serving as an expert witness for Johnson & Johnson.

SOURCE: Bradley SE et al. Am J Obstet Gynecol. 2020. doi: 10.1016/j.ajog.2020.06.002.

Patients hospitalized for sepsis are more likely to require readmission within a month after discharge if they live in disadvantaged neighborhoods, according to a study published in Critical Care Medicine.

The association between living in a disadvantaged neighborhood and 30-day readmission remained significant even after adjustment for “individual demographic variables, active tobacco use, length of index hospitalization, severity of acute and chronic morbidity, and place of initial discharge,” wrote Panagis Galiatsatos, MD, of Johns Hopkins University in Baltimore, and colleagues.

“Our findings suggest the need for interventions that emphasize neighborhood-level socioeconomic variables in addition to individual-level efforts in an effort to promote and achieve health equity for patients who survive a hospitalization due to sepsis,” the authors wrote. “With a third of our cohort rehospitalized with infections, and other studies emphasizing that the most common readmission diagnosis was infection, attention toward both anticipating and attenuating the risk of infection in sepsis survivors, especially among those who live in higher risk neighborhoods, must be a priority for the prevention of readmissions.”

Although she did not find the study results surprising, Eva DuGoff, PhD, a senior managing consultant with the Berkeley Research Group and a visiting assistant professor at University of Maryland School of Public Health, College Park, said in an interview that she was impressed with how clinically rigorous the analysis was, both in confirming an accurate sepsis diagnosis and in using the more refined measure of the Area Deprivation Index (ADI) to assess neighborhood disadvantage.

“I think it makes sense that people who have less means and are in neighborhoods with fewer resources would run into more issues and would need to return to the hospital, above and beyond the clinical risk factors, such as smoking and chronic conditions,” said Dr. DuGoff, who studies health disparities but was not involved in this study.

Shayla N.M. Durfey MD, ScM, a pediatric resident at Hasbro Children’s Hospital in Providence, R.I., said in an interview she was similarly unsurprised by the findings.

“People who live in disadvantaged neighborhoods may have less access to walking spaces, healthy food, and safe housing and more exposure to poor air quality, toxic stress, and violence – any of which can negatively impact health or recovery from illness through stress responses, nutritional deficiencies, or comorbidities, such as reactive airway disease, obesity, hypertension, and diabetes,” said Dr. Durfey, who studies health disparities but was not involved in this study. “Our research has found these neighborhood-level factors often matter above and beyond individual social determinants of health.”

Dr. Galiatsatos and associates conducted a retrospective study in Baltimore that compared readmission rates in 2017 at Johns Hopkins Bayview Medical Center among patients discharged after a hospitalization for sepsis, coded via ICD-10. They relied on the ADI to categorize the neighborhoods of patients’ residential addresses. The ADI rates various socioeconomic components, including income, education, employment, and housing characteristics, on a scale of 1-100 in geographic blocks, with higher score indicating a greater level of disadvantage.

Among 647 hospitalized patients with an ICD-10 code of sepsis who also met criteria for sepsis or septic shock per the Sepsis-3 definition, 17.9% were excluded from the analysis because they died or were transferred to hospice care. The other 531 patients had an average age of 61, and just under one-third (30.9%) were active smokers. Their average length of stay was 6.9 days, with a mean Charlson Comorbidity Index of 4.2 and a mean Sequential Organ Failure Assessment score of 4.9.

The average ADI for all the patients was 54.2, but the average score was 63 for the 22% of patients who were readmitted within 30 days of initial discharge, compared with an average 51.8 for patients not readmitted (P < .001).

Among those 117 readmitted, “39 patients had a reinfection, 68 had an exacerbation of their chronic conditions, and 10 were admitted for ‘concerning symptoms’ without a primary admitting diagnosis,” the investigators reported. Because “a third of our cohort was readmitted with an infection, it is possible that more disadvantaged neighborhoods created more challenges for a person’s immune system, which may be compromised after recovering from sepsis.”

Dr. DuGoff further noted that health literacy may be lower among people living in less advantaged neighborhoods.

“A number of studies suggest when patients leave the hospital, they’re not sure what they need to do. The language is complicated, and it’s hard to know what kind of medication to take when, and when you’re supposed to return to the doctor or the hospital,” Dr. DuGoff said. “Managing all of that can be pretty scary for people, particularly after a traumatic experience with sepsis at the hospital.”

Most patients had been discharged home (67.3%), but the 31.6% discharged to a skilled nursing facility had a greater likelihood of readmission, compared with those discharged home (P < .01); 1% were discharged to acute rehabilitation. The average length of stay during the index hospitalization was also greater for those readmitted (8.7 days) than for those not readmitted (6.4 days). The groups did not differ in terms of their acute organ dysfunction or severity of their comorbidities.

However, even after adjustment for these factors, “neighborhood disadvantage remained significantly associated with 30-day rehospitalization in patients who were discharged with sepsis,” the authors said. Specifically, each additional standard deviation greater in patients’ ADI was associated with increased risk of 30-day readmission (P < .001).

“Given that the ADI is a composite score, we cannot identify which component is the predominant driver of rehospitalizations for patients who survive sepsis,” the authors wrote. “However, all components that make up the index are intertwined, and policy efforts targeting one (i.e., unemployment) will likely impact others (i.e., housing).”

Dr. Durfey said that medical schools have not traditionally provided training related to management of social risk factors, although this is changing in more recent curricula. But the findings still have clinical relevance for practitioners.

“Certainly, the first step is awareness of where and how patients live and being mindful of how treatment plans may be impacted by social factors at both the individual and community levels,” Dr. Durfey said. “An important part of this is working in partnership with social workers and case managers. Importantly, clinicians can also partner with disadvantaged communities to advocate for improved conditions through policy change and act as expert witnesses to how neighborhood level factors impact health.”

Dr. DuGoff also wondered what implications these findings might have currently, with regards to COVID-19.

“People living in disadvantaged neighborhoods are already at higher risk for getting the disease, and this study raises really good questions about how we should be monitoring discharge now in anticipation of these types of issues,” she said.

The authors noted that their study is cross-sectional and cannot indicate causation, and the findings of a single urban institution may not be generalizable elsewhere. They also did not consider what interventions individual patients had during their index hospitalization that could have increased frailty.

The study did not note external funding. One coauthor of the study, Suchi Saria, PhD, reported receiving honoraria and travel reimbursement from two dozen biotechnology companies for keynotes and advisory board service; she also holds equity in Patient Ping and Bayesian Health. The other authors reported no industry disclosures. In addition to consulting for Berkeley Research Group, Dr. DuGoff has received a past honorarium from Zimmer Biomet. Dr. Durfey has no disclosures.

SOURCE: Galiatsatos P et al. Crit Care Med. 2020 Jun;48(6):808-14.

Patients hospitalized for sepsis are more likely to require readmission within a month after discharge if they live in disadvantaged neighborhoods, according to a study published in Critical Care Medicine.

The association between living in a disadvantaged neighborhood and 30-day readmission remained significant even after adjustment for “individual demographic variables, active tobacco use, length of index hospitalization, severity of acute and chronic morbidity, and place of initial discharge,” wrote Panagis Galiatsatos, MD, of Johns Hopkins University in Baltimore, and colleagues.

“Our findings suggest the need for interventions that emphasize neighborhood-level socioeconomic variables in addition to individual-level efforts in an effort to promote and achieve health equity for patients who survive a hospitalization due to sepsis,” the authors wrote. “With a third of our cohort rehospitalized with infections, and other studies emphasizing that the most common readmission diagnosis was infection, attention toward both anticipating and attenuating the risk of infection in sepsis survivors, especially among those who live in higher risk neighborhoods, must be a priority for the prevention of readmissions.”

Although she did not find the study results surprising, Eva DuGoff, PhD, a senior managing consultant with the Berkeley Research Group and a visiting assistant professor at University of Maryland School of Public Health, College Park, said in an interview that she was impressed with how clinically rigorous the analysis was, both in confirming an accurate sepsis diagnosis and in using the more refined measure of the Area Deprivation Index (ADI) to assess neighborhood disadvantage.

“I think it makes sense that people who have less means and are in neighborhoods with fewer resources would run into more issues and would need to return to the hospital, above and beyond the clinical risk factors, such as smoking and chronic conditions,” said Dr. DuGoff, who studies health disparities but was not involved in this study.

Shayla N.M. Durfey MD, ScM, a pediatric resident at Hasbro Children’s Hospital in Providence, R.I., said in an interview she was similarly unsurprised by the findings.

“People who live in disadvantaged neighborhoods may have less access to walking spaces, healthy food, and safe housing and more exposure to poor air quality, toxic stress, and violence – any of which can negatively impact health or recovery from illness through stress responses, nutritional deficiencies, or comorbidities, such as reactive airway disease, obesity, hypertension, and diabetes,” said Dr. Durfey, who studies health disparities but was not involved in this study. “Our research has found these neighborhood-level factors often matter above and beyond individual social determinants of health.”

Dr. Galiatsatos and associates conducted a retrospective study in Baltimore that compared readmission rates in 2017 at Johns Hopkins Bayview Medical Center among patients discharged after a hospitalization for sepsis, coded via ICD-10. They relied on the ADI to categorize the neighborhoods of patients’ residential addresses. The ADI rates various socioeconomic components, including income, education, employment, and housing characteristics, on a scale of 1-100 in geographic blocks, with higher score indicating a greater level of disadvantage.

Among 647 hospitalized patients with an ICD-10 code of sepsis who also met criteria for sepsis or septic shock per the Sepsis-3 definition, 17.9% were excluded from the analysis because they died or were transferred to hospice care. The other 531 patients had an average age of 61, and just under one-third (30.9%) were active smokers. Their average length of stay was 6.9 days, with a mean Charlson Comorbidity Index of 4.2 and a mean Sequential Organ Failure Assessment score of 4.9.

The average ADI for all the patients was 54.2, but the average score was 63 for the 22% of patients who were readmitted within 30 days of initial discharge, compared with an average 51.8 for patients not readmitted (P < .001).

Among those 117 readmitted, “39 patients had a reinfection, 68 had an exacerbation of their chronic conditions, and 10 were admitted for ‘concerning symptoms’ without a primary admitting diagnosis,” the investigators reported. Because “a third of our cohort was readmitted with an infection, it is possible that more disadvantaged neighborhoods created more challenges for a person’s immune system, which may be compromised after recovering from sepsis.”

Dr. DuGoff further noted that health literacy may be lower among people living in less advantaged neighborhoods.

“A number of studies suggest when patients leave the hospital, they’re not sure what they need to do. The language is complicated, and it’s hard to know what kind of medication to take when, and when you’re supposed to return to the doctor or the hospital,” Dr. DuGoff said. “Managing all of that can be pretty scary for people, particularly after a traumatic experience with sepsis at the hospital.”

Most patients had been discharged home (67.3%), but the 31.6% discharged to a skilled nursing facility had a greater likelihood of readmission, compared with those discharged home (P < .01); 1% were discharged to acute rehabilitation. The average length of stay during the index hospitalization was also greater for those readmitted (8.7 days) than for those not readmitted (6.4 days). The groups did not differ in terms of their acute organ dysfunction or severity of their comorbidities.

However, even after adjustment for these factors, “neighborhood disadvantage remained significantly associated with 30-day rehospitalization in patients who were discharged with sepsis,” the authors said. Specifically, each additional standard deviation greater in patients’ ADI was associated with increased risk of 30-day readmission (P < .001).

“Given that the ADI is a composite score, we cannot identify which component is the predominant driver of rehospitalizations for patients who survive sepsis,” the authors wrote. “However, all components that make up the index are intertwined, and policy efforts targeting one (i.e., unemployment) will likely impact others (i.e., housing).”

Dr. Durfey said that medical schools have not traditionally provided training related to management of social risk factors, although this is changing in more recent curricula. But the findings still have clinical relevance for practitioners.

“Certainly, the first step is awareness of where and how patients live and being mindful of how treatment plans may be impacted by social factors at both the individual and community levels,” Dr. Durfey said. “An important part of this is working in partnership with social workers and case managers. Importantly, clinicians can also partner with disadvantaged communities to advocate for improved conditions through policy change and act as expert witnesses to how neighborhood level factors impact health.”

Dr. DuGoff also wondered what implications these findings might have currently, with regards to COVID-19.

“People living in disadvantaged neighborhoods are already at higher risk for getting the disease, and this study raises really good questions about how we should be monitoring discharge now in anticipation of these types of issues,” she said.

The authors noted that their study is cross-sectional and cannot indicate causation, and the findings of a single urban institution may not be generalizable elsewhere. They also did not consider what interventions individual patients had during their index hospitalization that could have increased frailty.

The study did not note external funding. One coauthor of the study, Suchi Saria, PhD, reported receiving honoraria and travel reimbursement from two dozen biotechnology companies for keynotes and advisory board service; she also holds equity in Patient Ping and Bayesian Health. The other authors reported no industry disclosures. In addition to consulting for Berkeley Research Group, Dr. DuGoff has received a past honorarium from Zimmer Biomet. Dr. Durfey has no disclosures.

SOURCE: Galiatsatos P et al. Crit Care Med. 2020 Jun;48(6):808-14.

Patients hospitalized for sepsis are more likely to require readmission within a month after discharge if they live in disadvantaged neighborhoods, according to a study published in Critical Care Medicine.

The association between living in a disadvantaged neighborhood and 30-day readmission remained significant even after adjustment for “individual demographic variables, active tobacco use, length of index hospitalization, severity of acute and chronic morbidity, and place of initial discharge,” wrote Panagis Galiatsatos, MD, of Johns Hopkins University in Baltimore, and colleagues.

“Our findings suggest the need for interventions that emphasize neighborhood-level socioeconomic variables in addition to individual-level efforts in an effort to promote and achieve health equity for patients who survive a hospitalization due to sepsis,” the authors wrote. “With a third of our cohort rehospitalized with infections, and other studies emphasizing that the most common readmission diagnosis was infection, attention toward both anticipating and attenuating the risk of infection in sepsis survivors, especially among those who live in higher risk neighborhoods, must be a priority for the prevention of readmissions.”

Although she did not find the study results surprising, Eva DuGoff, PhD, a senior managing consultant with the Berkeley Research Group and a visiting assistant professor at University of Maryland School of Public Health, College Park, said in an interview that she was impressed with how clinically rigorous the analysis was, both in confirming an accurate sepsis diagnosis and in using the more refined measure of the Area Deprivation Index (ADI) to assess neighborhood disadvantage.

“I think it makes sense that people who have less means and are in neighborhoods with fewer resources would run into more issues and would need to return to the hospital, above and beyond the clinical risk factors, such as smoking and chronic conditions,” said Dr. DuGoff, who studies health disparities but was not involved in this study.

Shayla N.M. Durfey MD, ScM, a pediatric resident at Hasbro Children’s Hospital in Providence, R.I., said in an interview she was similarly unsurprised by the findings.

“People who live in disadvantaged neighborhoods may have less access to walking spaces, healthy food, and safe housing and more exposure to poor air quality, toxic stress, and violence – any of which can negatively impact health or recovery from illness through stress responses, nutritional deficiencies, or comorbidities, such as reactive airway disease, obesity, hypertension, and diabetes,” said Dr. Durfey, who studies health disparities but was not involved in this study. “Our research has found these neighborhood-level factors often matter above and beyond individual social determinants of health.”

Dr. Galiatsatos and associates conducted a retrospective study in Baltimore that compared readmission rates in 2017 at Johns Hopkins Bayview Medical Center among patients discharged after a hospitalization for sepsis, coded via ICD-10. They relied on the ADI to categorize the neighborhoods of patients’ residential addresses. The ADI rates various socioeconomic components, including income, education, employment, and housing characteristics, on a scale of 1-100 in geographic blocks, with higher score indicating a greater level of disadvantage.

Among 647 hospitalized patients with an ICD-10 code of sepsis who also met criteria for sepsis or septic shock per the Sepsis-3 definition, 17.9% were excluded from the analysis because they died or were transferred to hospice care. The other 531 patients had an average age of 61, and just under one-third (30.9%) were active smokers. Their average length of stay was 6.9 days, with a mean Charlson Comorbidity Index of 4.2 and a mean Sequential Organ Failure Assessment score of 4.9.

The average ADI for all the patients was 54.2, but the average score was 63 for the 22% of patients who were readmitted within 30 days of initial discharge, compared with an average 51.8 for patients not readmitted (P < .001).

Among those 117 readmitted, “39 patients had a reinfection, 68 had an exacerbation of their chronic conditions, and 10 were admitted for ‘concerning symptoms’ without a primary admitting diagnosis,” the investigators reported. Because “a third of our cohort was readmitted with an infection, it is possible that more disadvantaged neighborhoods created more challenges for a person’s immune system, which may be compromised after recovering from sepsis.”

Dr. DuGoff further noted that health literacy may be lower among people living in less advantaged neighborhoods.

“A number of studies suggest when patients leave the hospital, they’re not sure what they need to do. The language is complicated, and it’s hard to know what kind of medication to take when, and when you’re supposed to return to the doctor or the hospital,” Dr. DuGoff said. “Managing all of that can be pretty scary for people, particularly after a traumatic experience with sepsis at the hospital.”

Most patients had been discharged home (67.3%), but the 31.6% discharged to a skilled nursing facility had a greater likelihood of readmission, compared with those discharged home (P < .01); 1% were discharged to acute rehabilitation. The average length of stay during the index hospitalization was also greater for those readmitted (8.7 days) than for those not readmitted (6.4 days). The groups did not differ in terms of their acute organ dysfunction or severity of their comorbidities.

However, even after adjustment for these factors, “neighborhood disadvantage remained significantly associated with 30-day rehospitalization in patients who were discharged with sepsis,” the authors said. Specifically, each additional standard deviation greater in patients’ ADI was associated with increased risk of 30-day readmission (P < .001).

“Given that the ADI is a composite score, we cannot identify which component is the predominant driver of rehospitalizations for patients who survive sepsis,” the authors wrote. “However, all components that make up the index are intertwined, and policy efforts targeting one (i.e., unemployment) will likely impact others (i.e., housing).”

Dr. Durfey said that medical schools have not traditionally provided training related to management of social risk factors, although this is changing in more recent curricula. But the findings still have clinical relevance for practitioners.

“Certainly, the first step is awareness of where and how patients live and being mindful of how treatment plans may be impacted by social factors at both the individual and community levels,” Dr. Durfey said. “An important part of this is working in partnership with social workers and case managers. Importantly, clinicians can also partner with disadvantaged communities to advocate for improved conditions through policy change and act as expert witnesses to how neighborhood level factors impact health.”

Dr. DuGoff also wondered what implications these findings might have currently, with regards to COVID-19.

“People living in disadvantaged neighborhoods are already at higher risk for getting the disease, and this study raises really good questions about how we should be monitoring discharge now in anticipation of these types of issues,” she said.

The authors noted that their study is cross-sectional and cannot indicate causation, and the findings of a single urban institution may not be generalizable elsewhere. They also did not consider what interventions individual patients had during their index hospitalization that could have increased frailty.

The study did not note external funding. One coauthor of the study, Suchi Saria, PhD, reported receiving honoraria and travel reimbursement from two dozen biotechnology companies for keynotes and advisory board service; she also holds equity in Patient Ping and Bayesian Health. The other authors reported no industry disclosures. In addition to consulting for Berkeley Research Group, Dr. DuGoff has received a past honorarium from Zimmer Biomet. Dr. Durfey has no disclosures.

SOURCE: Galiatsatos P et al. Crit Care Med. 2020 Jun;48(6):808-14.

Planning for reduced use of opioids in pain management involves identifying appropriate patients and managing their expectations, according to according to Timothy E. Miller, MB, ChB, FRCA, of Duke University, Durham, N.C., who is president of the American Society for Enhanced Recovery.

Multimodal analgesia plans can be a beneficial part of enhanced recovery and may reduce or eliminate the need for opioids in some patients, he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

Dr. Miller shared a treatment algorithm for achieving optimal analgesia in patients after colorectal surgery that combines intravenous or oral analgesia with local anesthetics and additional nonopioid options. The algorithm involves choosing NSAIDs, acetaminophen, or gabapentin for IV/oral use. In addition, options for local anesthetic include with a choice of single-shot transversus abdominis plane (TAP) block.

Careful patient selection is key to an opioid-free or opioid reduced anesthetic strategy, Dr. Miller said. The appropriate patients have “no chronic opioids, no anxiety, and the desire to avoid opioid side effects,” he said.

Opioid-free or opioid-reduced strategies include realigning patient expectations to prepare for pain at a level of 2-4 on a scale of 10 as “expected and reasonable,” he said. Patients given no opioids or reduced opioids may report cramping after laparoscopic surgery, as well as shoulder pain that is referred from the CO₂ bubble under the diaphragm, he said. However, opioids don’t treat the shoulder pain well, and “walking or changing position usually relieves this pain,” and it usually resolves within 24 hours, Dr. Miller noted. “Just letting the patient know what is expected in terms of pain relief in their recovery is hugely important,” he said.

The optimal analgesia after surgery is a plan that combines optimized patient comfort with the fastest functional recovery and the fewest side effects, he emphasized.

Optimized patient comfort includes optimal pain ratings at rest and with movement, a decreasing impact of pain on emotion, function, and sleep disruption, and an improvement in the patient experience, he said. The fastest functional recovery is defined as a return to drinking liquids, eating solid foods, performing activities of daily living, and maintaining normal bladder, bowel, and cognitive function. Side effects to be considered in analgesia included nausea, vomiting, sedation, ileus, itching, dizziness, and delirium, he said.

In an unpublished study, Dr. Miller and colleagues eliminated opioids intraoperatively in a series of 56 cases of laparoscopic cholecystectomy and found significantly less opioids needed in the postanesthesia care unit (PACU). In addition, opioid-free patients had significantly shorter length of stay in the PACU, he said. “We are writing this up for publication and looking into doing larger studies,” Dr. Miller said.

Questions include whether the opioid-free technique translates more broadly, he said.

In addition, it is important to continue to collect data and study methods to treat pain and reduce opioid use perioperatively, Dr. Miller said. Some ongoing concerns include data surrounding the use of gabapentin and possible association with respiratory depression, he noted. Several meta-analyses have suggested that “gabapentinoids (gabapentin, pregabalin) when given as a single dose preoperatively are associated with a decrease in postoperative pain and opioid consumption at 24 hours,” said Dr. Miller. “When gabapentinoids are included in multimodal analgesic regimens, intraoperative opioids must be reduced, and increased vigilance for respiratory depression may be warranted, especially in elderly patients,” he said.

Overall, opioid-free anesthesia is both feasible and appropriate in certain patient populations, Dr. Miller concluded. “Implement your pathway and measure your outcomes with timely feedback so you can revise your protocol based on data,” he emphasized.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Miller disclosed relationships with Edwards Lifesciences, and serving as a board member for the Perioperative Quality Initiative and as a founding member of the Morpheus Consortium.

Planning for reduced use of opioids in pain management involves identifying appropriate patients and managing their expectations, according to according to Timothy E. Miller, MB, ChB, FRCA, of Duke University, Durham, N.C., who is president of the American Society for Enhanced Recovery.

Multimodal analgesia plans can be a beneficial part of enhanced recovery and may reduce or eliminate the need for opioids in some patients, he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

Dr. Miller shared a treatment algorithm for achieving optimal analgesia in patients after colorectal surgery that combines intravenous or oral analgesia with local anesthetics and additional nonopioid options. The algorithm involves choosing NSAIDs, acetaminophen, or gabapentin for IV/oral use. In addition, options for local anesthetic include with a choice of single-shot transversus abdominis plane (TAP) block.

Careful patient selection is key to an opioid-free or opioid reduced anesthetic strategy, Dr. Miller said. The appropriate patients have “no chronic opioids, no anxiety, and the desire to avoid opioid side effects,” he said.

Opioid-free or opioid-reduced strategies include realigning patient expectations to prepare for pain at a level of 2-4 on a scale of 10 as “expected and reasonable,” he said. Patients given no opioids or reduced opioids may report cramping after laparoscopic surgery, as well as shoulder pain that is referred from the CO₂ bubble under the diaphragm, he said. However, opioids don’t treat the shoulder pain well, and “walking or changing position usually relieves this pain,” and it usually resolves within 24 hours, Dr. Miller noted. “Just letting the patient know what is expected in terms of pain relief in their recovery is hugely important,” he said.

The optimal analgesia after surgery is a plan that combines optimized patient comfort with the fastest functional recovery and the fewest side effects, he emphasized.

Optimized patient comfort includes optimal pain ratings at rest and with movement, a decreasing impact of pain on emotion, function, and sleep disruption, and an improvement in the patient experience, he said. The fastest functional recovery is defined as a return to drinking liquids, eating solid foods, performing activities of daily living, and maintaining normal bladder, bowel, and cognitive function. Side effects to be considered in analgesia included nausea, vomiting, sedation, ileus, itching, dizziness, and delirium, he said.

In an unpublished study, Dr. Miller and colleagues eliminated opioids intraoperatively in a series of 56 cases of laparoscopic cholecystectomy and found significantly less opioids needed in the postanesthesia care unit (PACU). In addition, opioid-free patients had significantly shorter length of stay in the PACU, he said. “We are writing this up for publication and looking into doing larger studies,” Dr. Miller said.

Questions include whether the opioid-free technique translates more broadly, he said.

In addition, it is important to continue to collect data and study methods to treat pain and reduce opioid use perioperatively, Dr. Miller said. Some ongoing concerns include data surrounding the use of gabapentin and possible association with respiratory depression, he noted. Several meta-analyses have suggested that “gabapentinoids (gabapentin, pregabalin) when given as a single dose preoperatively are associated with a decrease in postoperative pain and opioid consumption at 24 hours,” said Dr. Miller. “When gabapentinoids are included in multimodal analgesic regimens, intraoperative opioids must be reduced, and increased vigilance for respiratory depression may be warranted, especially in elderly patients,” he said.

Overall, opioid-free anesthesia is both feasible and appropriate in certain patient populations, Dr. Miller concluded. “Implement your pathway and measure your outcomes with timely feedback so you can revise your protocol based on data,” he emphasized.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Miller disclosed relationships with Edwards Lifesciences, and serving as a board member for the Perioperative Quality Initiative and as a founding member of the Morpheus Consortium.

Planning for reduced use of opioids in pain management involves identifying appropriate patients and managing their expectations, according to according to Timothy E. Miller, MB, ChB, FRCA, of Duke University, Durham, N.C., who is president of the American Society for Enhanced Recovery.

Multimodal analgesia plans can be a beneficial part of enhanced recovery and may reduce or eliminate the need for opioids in some patients, he said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

Dr. Miller shared a treatment algorithm for achieving optimal analgesia in patients after colorectal surgery that combines intravenous or oral analgesia with local anesthetics and additional nonopioid options. The algorithm involves choosing NSAIDs, acetaminophen, or gabapentin for IV/oral use. In addition, options for local anesthetic include with a choice of single-shot transversus abdominis plane (TAP) block.

Careful patient selection is key to an opioid-free or opioid reduced anesthetic strategy, Dr. Miller said. The appropriate patients have “no chronic opioids, no anxiety, and the desire to avoid opioid side effects,” he said.

Opioid-free or opioid-reduced strategies include realigning patient expectations to prepare for pain at a level of 2-4 on a scale of 10 as “expected and reasonable,” he said. Patients given no opioids or reduced opioids may report cramping after laparoscopic surgery, as well as shoulder pain that is referred from the CO₂ bubble under the diaphragm, he said. However, opioids don’t treat the shoulder pain well, and “walking or changing position usually relieves this pain,” and it usually resolves within 24 hours, Dr. Miller noted. “Just letting the patient know what is expected in terms of pain relief in their recovery is hugely important,” he said.

The optimal analgesia after surgery is a plan that combines optimized patient comfort with the fastest functional recovery and the fewest side effects, he emphasized.

Optimized patient comfort includes optimal pain ratings at rest and with movement, a decreasing impact of pain on emotion, function, and sleep disruption, and an improvement in the patient experience, he said. The fastest functional recovery is defined as a return to drinking liquids, eating solid foods, performing activities of daily living, and maintaining normal bladder, bowel, and cognitive function. Side effects to be considered in analgesia included nausea, vomiting, sedation, ileus, itching, dizziness, and delirium, he said.

In an unpublished study, Dr. Miller and colleagues eliminated opioids intraoperatively in a series of 56 cases of laparoscopic cholecystectomy and found significantly less opioids needed in the postanesthesia care unit (PACU). In addition, opioid-free patients had significantly shorter length of stay in the PACU, he said. “We are writing this up for publication and looking into doing larger studies,” Dr. Miller said.

Questions include whether the opioid-free technique translates more broadly, he said.

In addition, it is important to continue to collect data and study methods to treat pain and reduce opioid use perioperatively, Dr. Miller said. Some ongoing concerns include data surrounding the use of gabapentin and possible association with respiratory depression, he noted. Several meta-analyses have suggested that “gabapentinoids (gabapentin, pregabalin) when given as a single dose preoperatively are associated with a decrease in postoperative pain and opioid consumption at 24 hours,” said Dr. Miller. “When gabapentinoids are included in multimodal analgesic regimens, intraoperative opioids must be reduced, and increased vigilance for respiratory depression may be warranted, especially in elderly patients,” he said.

Overall, opioid-free anesthesia is both feasible and appropriate in certain patient populations, Dr. Miller concluded. “Implement your pathway and measure your outcomes with timely feedback so you can revise your protocol based on data,” he emphasized.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Miller disclosed relationships with Edwards Lifesciences, and serving as a board member for the Perioperative Quality Initiative and as a founding member of the Morpheus Consortium.

For surgical patients on chronic opioid therapy, the goals of pain management are to provide adequate analgesia, prevent withdrawal, and avoid relapse or worsening of opioid use, according to Stephanie B. Jones, MD, professor and chair of anesthesiology at Albany Medical College, New York.

“[With] any patient coming in for any sort of surgery, you should be considering multimodal pain management. That applies to the opioid use disorder patient as well,” Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

“The challenge of opioid-tolerant patients or opioid abuse patients is twofold – tolerance and hyperalgesia,” Dr. Jones said. Patient tolerance changes how patients perceive pain and respond to medication. Clinicians need to consider the “opioid debt,” defined as the daily amount of opioid medication required by opioid-dependent patients to maintain their usual prehospitalization opioid levels, she explained. Also consider hyperalgesia, a change in pain perception “resulting in an increase in pain sensitivity to painful stimuli, thereby decreasing the analgesic effects of opioids,” Dr. Jones added.

A multimodal approach to pain management in patients on chronic opioids can include some opioids as appropriate, Dr. Jones said. Modulation of pain may draw on epidurals and nerve blocks, as well as managing CNS perception of pain through opioids or acetaminophen, and also using systemic options such as alpha-2 agonists and tramadol, she said.

Studies have shown that opioid abuse or dependence were associated with increased readmission rates, length of stay, and health care costs in surgery patients, said Dr. Jones. However, switching opioids and managing equivalents is complex, and “equianalgesic conversions serve only as a general guide to estimate opioid dose equivalents,” according to UpToDate’s, “Management of acute pain in the patient chronically using opioids,” she said.

Dr. Jones also addressed the issue of using hospitalization as an opportunity to help patients with untreated opioid use disorder. Medication-assisted options include methadone, buprenorphine, and naltrexone.

“One problem with methadone is that there are a lot of medications interactions,” she said. Buprenorphine has the advantage of being long-lasting, and is formulated with naloxone which deters injection. “Because it is a partial agonist, there is a lower risk of overdose and sedation,” and it has fewer medication interactions. However, some doctors are reluctant to prescribe it and there is some risk of medication diversion, she said.

Naltrexone is newer to the role of treating opioid use disorder, Dr. Jones said. “It can cause acute withdrawal because it is a full opioid antagonist,” she noted. However, naltrexone itself causes no withdrawal if stopped, and no respiratory depression or sedation, said Dr. Jones.

“Utilize addiction services in your hospital if you suspect a patient may be at risk for opioid use disorder,” and engage these services early, she emphasized.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Jones had no financial conflicts to disclose.

For surgical patients on chronic opioid therapy, the goals of pain management are to provide adequate analgesia, prevent withdrawal, and avoid relapse or worsening of opioid use, according to Stephanie B. Jones, MD, professor and chair of anesthesiology at Albany Medical College, New York.

“[With] any patient coming in for any sort of surgery, you should be considering multimodal pain management. That applies to the opioid use disorder patient as well,” Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

“The challenge of opioid-tolerant patients or opioid abuse patients is twofold – tolerance and hyperalgesia,” Dr. Jones said. Patient tolerance changes how patients perceive pain and respond to medication. Clinicians need to consider the “opioid debt,” defined as the daily amount of opioid medication required by opioid-dependent patients to maintain their usual prehospitalization opioid levels, she explained. Also consider hyperalgesia, a change in pain perception “resulting in an increase in pain sensitivity to painful stimuli, thereby decreasing the analgesic effects of opioids,” Dr. Jones added.

A multimodal approach to pain management in patients on chronic opioids can include some opioids as appropriate, Dr. Jones said. Modulation of pain may draw on epidurals and nerve blocks, as well as managing CNS perception of pain through opioids or acetaminophen, and also using systemic options such as alpha-2 agonists and tramadol, she said.

Studies have shown that opioid abuse or dependence were associated with increased readmission rates, length of stay, and health care costs in surgery patients, said Dr. Jones. However, switching opioids and managing equivalents is complex, and “equianalgesic conversions serve only as a general guide to estimate opioid dose equivalents,” according to UpToDate’s, “Management of acute pain in the patient chronically using opioids,” she said.

Dr. Jones also addressed the issue of using hospitalization as an opportunity to help patients with untreated opioid use disorder. Medication-assisted options include methadone, buprenorphine, and naltrexone.

“One problem with methadone is that there are a lot of medications interactions,” she said. Buprenorphine has the advantage of being long-lasting, and is formulated with naloxone which deters injection. “Because it is a partial agonist, there is a lower risk of overdose and sedation,” and it has fewer medication interactions. However, some doctors are reluctant to prescribe it and there is some risk of medication diversion, she said.

Naltrexone is newer to the role of treating opioid use disorder, Dr. Jones said. “It can cause acute withdrawal because it is a full opioid antagonist,” she noted. However, naltrexone itself causes no withdrawal if stopped, and no respiratory depression or sedation, said Dr. Jones.

“Utilize addiction services in your hospital if you suspect a patient may be at risk for opioid use disorder,” and engage these services early, she emphasized.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Jones had no financial conflicts to disclose.

For surgical patients on chronic opioid therapy, the goals of pain management are to provide adequate analgesia, prevent withdrawal, and avoid relapse or worsening of opioid use, according to Stephanie B. Jones, MD, professor and chair of anesthesiology at Albany Medical College, New York.

“[With] any patient coming in for any sort of surgery, you should be considering multimodal pain management. That applies to the opioid use disorder patient as well,” Dr. Jones said in a presentation at the virtual Annual Minimally Invasive Surgery Symposium sponsored by Global Academy for Medical Education.

“The challenge of opioid-tolerant patients or opioid abuse patients is twofold – tolerance and hyperalgesia,” Dr. Jones said. Patient tolerance changes how patients perceive pain and respond to medication. Clinicians need to consider the “opioid debt,” defined as the daily amount of opioid medication required by opioid-dependent patients to maintain their usual prehospitalization opioid levels, she explained. Also consider hyperalgesia, a change in pain perception “resulting in an increase in pain sensitivity to painful stimuli, thereby decreasing the analgesic effects of opioids,” Dr. Jones added.

A multimodal approach to pain management in patients on chronic opioids can include some opioids as appropriate, Dr. Jones said. Modulation of pain may draw on epidurals and nerve blocks, as well as managing CNS perception of pain through opioids or acetaminophen, and also using systemic options such as alpha-2 agonists and tramadol, she said.

Studies have shown that opioid abuse or dependence were associated with increased readmission rates, length of stay, and health care costs in surgery patients, said Dr. Jones. However, switching opioids and managing equivalents is complex, and “equianalgesic conversions serve only as a general guide to estimate opioid dose equivalents,” according to UpToDate’s, “Management of acute pain in the patient chronically using opioids,” she said.

Dr. Jones also addressed the issue of using hospitalization as an opportunity to help patients with untreated opioid use disorder. Medication-assisted options include methadone, buprenorphine, and naltrexone.

“One problem with methadone is that there are a lot of medications interactions,” she said. Buprenorphine has the advantage of being long-lasting, and is formulated with naloxone which deters injection. “Because it is a partial agonist, there is a lower risk of overdose and sedation,” and it has fewer medication interactions. However, some doctors are reluctant to prescribe it and there is some risk of medication diversion, she said.

Naltrexone is newer to the role of treating opioid use disorder, Dr. Jones said. “It can cause acute withdrawal because it is a full opioid antagonist,” she noted. However, naltrexone itself causes no withdrawal if stopped, and no respiratory depression or sedation, said Dr. Jones.

“Utilize addiction services in your hospital if you suspect a patient may be at risk for opioid use disorder,” and engage these services early, she emphasized.

Global Academy for Medical Education and this news organization are owned by the same parent company.

Dr. Jones had no financial conflicts to disclose.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

[email protected]

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

[email protected]

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

Lung ultrasound has “high concordance” with radiologic findings in children with COVID-19, researchers wrote in Pediatrics.

They also noted the benefits that modality provides over other imaging techniques.

Marco Denina, MD, and colleagues from the pediatric infectious diseases unit at Regina Margherita Children’s Hospital in Turin, Italy, performed an observational study of eight children aged 0-17 years who were admitted to the hospital for COVID-19 between March 8 and 26, 2020. In seven of eight patients, the findings were concordant between imaging modalities; in the remaining patient, lung ultrasound (LUS) found an interstitial B-lines pattern that was not seen on radiography. In seven patients with pathologic ultrasound findings at baseline, the improvement or resolution of the subpleural consolidations or interstitial patterns was consistent with concomitant radiologic findings.

The authors cited the benefits of using point-of-care ultrasound instead of other modalities, such as CT. “First, it may reduce the number of radiologic examinations, lowering the radiation exposure of the patients,” they wrote. “Secondly, when performed at the bedside, LUS allows for the reduction of the patient’s movement within the hospital; thus, it lowers the number of health care workers and medical devices exposed to [SARS-CoV-2].”

One limitation of the study is the small sample size; however, the researchers felt the high concordance still suggests LUS is a reasonable method for COVID-19 patients.

There was no external funding for this study and the investigators had no relevant financial disclosures.

[email protected]

SOURCE: Denina M et al. Pediatrics. 2020 Jun. doi: 10.1542/peds.2020-1157.

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

COVID-19 now. The urban phase of the U.S. pandemic is leveling somewhat, while the rural phase is accelerating – in part because of food processing and handling industries. The pediatric burden has been surprisingly small, with the multisystem inflammatory disease (MIS-c) in children noted in several hundred cases now being seen across the country.

CDC

Next wave? Given ongoing COVID-19 disease, controversy rages about when and how to re-open the country. Regardless how more reopening occurs over the next months, we should expect a next or ongoing COVID-19 wave, particularly given loss of social distancing during social justice protests. A sawtooth disease prevalence pattern is predicted by many experts: a drop in prevalence leading to reopening, leading to scattered prevalence increases and regional if not local restriction tightening, followed by another drop in prevalence. Then “rinse and repeat” until 70% of the population is immune either by disease experience or vaccine-induced immunity, likely sometime in 2021.

Influenza too. A COVID-19 up-cycle is likely during influenza season, although influenza season’s onset could be altered because of whatever social distancing rules are in place in November and December. That said, we need to consider the worst. We have seen what happens if we fail to prepare and then react only after a prevalent respiratory infection has surged into the overall population. Best estimates are that at most 20% of the U.S. population is currently immune to SARS-CoV-2. Given that at least some of that 20% of individuals currently immune to SARS-CoV-2 will lose their neutralizing antibody over the next 4-6 months, we can still expect 70%-80% of the U.S. population to be susceptible to SARS-CoV-2 infection in the fall of 2020.

Pediatric preparedness. As pediatric providers, we have struggled with lower patient loads and dramatic income losses/declines. Many clinics/offices’ attendance remain less than 50% of pre–COVID-19 levels, with necessary furloughs of personnel and spotty office hours. But influenza is coming, and SARS-CoV-2 will not be gone yet. How do we prepare for concurrent influenza and COVID-19?

The annual purchase/administration of influenza vaccine in summer/fall is expensive, time consuming, and logistically difficult even in the best times. Given the loss of income, likely reluctance of patients to come to clinics/offices if COVID-19 is still circulating, and likely need for some form of social distancing during late summer and early fall, how will providers, health departments, and hospitals implement influenza vaccine administration this year?

Minimize double whammy infections. Maximizing influenza vaccine uptake during the COVID-19 pandemic is super important. It is easy to understand why we should maximize influenza protection in SARS-CoV-2 vulnerables (elderly or persons with existing comorbidities). But is it as critical for otherwise healthy children? My answer is yes.

Children are not currently known as SARS-CoV-2 vectors, but children are excellent influenza vectors, shedding higher titers for longer than other age groups. As with SARS-CoV-2, influenza exposure is cumulative, i.e., the more intense and more frequently a person is exposed, the more likely that infection/disease will result. So, the fewer who get and can transmit influenza during the COVID-19 pandemic, the fewer people are likely to get a double whammy of SARS-CoV-2 concurrent or in tandem with influenza. Double whammy infections likely would further increase the medical care burden and return us to March-April crisis mode.

One alarming new question is whether recent influenza could make children vulnerable to SARS-CoV-2 and trigger hospitalizations. A surge in pediatric plus adult COVID-19 disease plus a surge in all-ages influenza disease would likely break the medical care system, at least in some areas.

CDC

Staggering COVID-19 burden. As of June 8, we have had approximately 2 million SARS-CoV-2 cases with 500,000 hospitalizations and 120,000 deaths. Over the past 10 years, total annual U.S. influenza hospitalizations ranged from 180,000 (2011-2012) to 825,000 (2017-2018). The interquartile range for hospitalization length of stay for influenza is 4-6 days¹ vs. 15-23 days² for SARS-CoV-2. One COVID-19 hospitalization uses hospital resources roughly equal to four influenza hospitalizations. To date COVID-19 hospitalizations have used resources equal to an estimated 1.9 million influenza hospitalizations – over twice the worst influenza season in this century – and we are still on the rise. We are likely not even halfway to truly controlling the U.S. pandemic, so expect another 500,000 hospitalizations – equal to another 1.9 million influenza hospitalizations. Further, pneumonia deaths have skyrocketed this year when COVID-19 was superimposed on the last third of influenza season. One hope is that widespread use of antivirals (for example, new antivirals, convalescent plasma, or other interventions) can reduce length of stay by 30% for COVID-19 hospitalizations, yet even with that the numbers remain grim.

Less influenza disease can free up medical resources. Planning ahead could prevent a bad influenza season (for example, up to 850,000 hospitalizations just for influenza). Can we preemptively use vaccine to reduce influenza hospitalizations below 2011-2012 levels – less than 150,000 hospitalizations? Perhaps, if we start by reducing pediatric influenza.

1. Aim to exceed 75% influenza vaccine uptake in your patients.

a. It is ambitious, but if there was ever a year that needed influenza herd immunity, it is 2020-2021.

2. Review practice/group/institution plans for vaccine purchase and ensure adequate personnel to administer vaccine.

3. Plan safe and efficient processes to vaccinate large numbers in August through November.

a. Consider that routine and influenza vaccines can be given concurrently with the annual uptick in school and sports physical examinations.

b. What social distancing and masking rules will be needed?

i. Will patients need to bring their own masks, or will you supply them?

c. What extra supplies and efforts are needed, e.g. hand sanitizer, new signage, 6-foot interval markings on floors or sidewalks, families calling from parking lot to announce their arrivals, etc.?

d. Remember younger patients need two doses before Dec 1, 2020.

e. Be creative, for example, are parking-lot tents for influenza vaccination feasible?

f. Can we partner with other providers to implement influenza vaccine–specific mass clinics?

Ramping up to give seasonal influenza vaccine in 2020 is daunting. But if we do not prepare, it will be even more difficult. Let’s make this the mildest influenza season in memory by vaccinating more than any time in memory – and by doing so, we can hope to blunt medical care burdens despite ongoing COVID-19 disease.
 

Dr. Harrison is professor of pediatrics and pediatric infectious diseases at Children’s Mercy Kansas City (Mo.). Children’s Mercy receives funding from GlaxoSmithKline, Merck, and Pfizer for vaccine research studies on which Dr. Harrison is an investigator. Email him at [email protected].
 

References

1.. HCUP Statistical Brief #253. 2019 Oct.

2. medrxiv. 2020 Apr 10. doi: 10.1101/2020.04.07.20057299.
 

As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.

Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.

“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”

The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”

The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”

From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.

The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.

There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.

Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.

The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.

If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.

On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.

“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.

“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”

Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”

One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.

Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.

“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”

SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.

As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.

Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.

“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”

The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”

The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”

From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.

The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.

There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.

Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.

The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.

If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.

On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.

“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.

“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”

Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”

One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.

Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.

“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”

SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.

As might be expected, the “EULAR [European League Against Rheumatism] provisional recommendations for the management of rheumatic and musculoskeletal diseases [RMDs] in the context of SARS-CoV-2” concur with much of the guidance already released on how best to manage patients during the current pandemic.

Highlights of the five overarching principles are that, contrary to earlier expectations, “there is no indication that patients with RMDs have an additional, or have a higher, risk of contracting the virus, or that they fare a worse course” than the general population, said the task force convener Robert Landewé, MD, PhD, professor of rheumatology at the University of Amsterdam.

“The second pertinent highlight is that, when it comes to managerial discussions, whether or not to stop or to start treatment for RMDs, rheumatologists should definitely be involved,” Dr. Landewé said during a live session at the annual European Congress of Rheumatology, held online this year due to COVID-19. “In practice, something that happens very often is that immunosuppressive drugs are stopped by medical specialists involved in the care of COVID but without any expertise in treating patients with rheumatic diseases. We should try to avoid that situation.”

The third highlight, something many rheumatologists may already be well aware of, is that rheumatology drugs are being used to treat COVID-19 patients without RMDs and a shortage of disease-modifying antirheumatic drugs (DMARDs) agents is a real possibility. As such, the fifth overarching highlight states that the availability of both synthetic and biologic DMARDs is “a delicate societal responsibility” and that “the off-label use of DMARDs in COVID-19 outside the context of clinical trials should be discouraged.”

The EULAR recommendation are now published online in Annals of the Rheumatic Diseases and they are “what you could call an unprecedented set of recommendations,” Dr. Landewé said. “We have never done this before,” he added, referring to the speed and way in which they had to be put together, remotely, and with little scientific evidence currently available. “Three months ago we hadn’t even heard about the virus.”

From the first patient being identified in the Hubei province of China in November 2019, to the first U.S. patient in the state of Washington on Jan. 20, 2020, and to the first European patient identified a little over 10 days later, the COVID-19 pandemic has taken the world by storm. It was only declared a pandemic on March 11, 2020, however, and Dr. Landewé noted that the response to the pandemic had been very variable – some countries locking down their borders early, while others took their time to make an appropriate response, if at all.

The rheumatology community was particularly concerned, Dr. Landewé said, because people with autoimmune diseases who were taking immunosuppressant drugs might be at higher risk for becoming infected with SARS-CoV-2, and may be at higher risk than others for a worse disease course. Thankfully, that seems not to be the case according to data that are emerging from new registries that have been set up, including EULAR’s own COVID-19 registry.

There are 13 recommendations that cover 4 themes: general measures and prevention of SARS-CoV-2 infection; the management of RMD patients during the pandemic; the management of RMD patients who have COVID-19; and the prevention of other pulmonary infections in RMD patients.

Highlighting the first three general recommendations, Dr. Landewé said: “Follow the regular guidelines in your country; if a patient with RMD does not have symptoms of COVID-19, simply continue RMD treatments,” albeit with a couple of exceptions.

The next four recommendation highlights are to avoid visits to the hospital or to the office; use remote monitoring via the telephone, for example; and if visits cannot be avoided, then take appropriate precautions. Finally, if you suspect a patient has COVID-19, do a test.

If patients test positive, then the next four recommendations cover what to do, such as continuing use of RMD treatments, but in the case of glucocorticoids this should be the lowest possible dose necessary. There is no consensus on what to do in cases of mild symptoms; the recommendation is to “decide on a case-by-case basis,” said Dr. Landewé. If a patient’s symptoms worsen, then “seek expert advice immediately and follow local treatment recommendations. The rheumatologist is not the expert to treat COVID-19,” he added. That responsibility lies with the pulmonologist, infectious disease specialist, or maybe the intensive care specialist, depending on local situations.

On the whole, the EULAR recommendations are pretty similar to those already released by the American College of Rheumatology, said Ted Mikuls, MD, of the University of Nebraska Medical Center, Omaha. The ACR recommendations are “slightly more prescriptive”, he suggested, with 25 final guidance statements. For example, general statements focused not only on the use of glucocorticoids, but also other medicines, such as antihypertensives.

“There’s really not a [lot of], I would say, major differences in the two efforts and that’s ... somewhat reassuring that we’re approaching the unknown from very different parts of the world, and driving in a very similar place,” commented Dr. Mikuls, who is a member of the ACR COVID-19 recommendations task force.

“I think one of the very important similarities that I would highlight is that, in the absence of known exposure, in the absence of COVID-19 infection, our panel felt very strongly about the importance of continuing rheumatic disease treatments,” Dr. Mikuls observed. The ACR guidelines also touch upon societal perspectives, including “some statements that were made very specific to lupus, and the use of antimalarials, given supply chain issues that we have encountered.”

Dr. Mikuls also said that the American recommendations emphasized that “you really have to manage active inflammatory rheumatic disease. Even in the context of the COVID-19 pandemic, given what we saw as the potential risk of unchecked inflammation and unchecked rheumatic disease.”

One notable difference, however, is that the European recommendations advise on immunizations and pneumonia prophylaxis, saying that all patients without COVID-19 symptoms should make sure they are up to date with any recommended vaccinations, “with a particular focus on pneumococcal and influenza vaccinations,” Dr. Landewé said.

Another difference is that the ACR recommendations are a living document and could potentially be updated monthly if the evidence arrives to allow that. In that sense, the American guidance is more agile, with EULAR expecting to update its recommendations every 3 months.

“The current evidence is extremely sparse and fragmented,” Dr. Landewé said. “We, as a task force are essentially flying blindly. We also have to cover many jurisdictions within Europe, with many conflicting opinions. So the last word to say is that updates are truly necessary, but we have to wait a while.”

SOURCE: Landewé RB et al. Ann Rheum Dis. 2020 Jun 5. doi: 10.1136/annrheumdis-2020-217877.